Engineer II, Drug Product Development
Core
Developing sterile drug product processes and products for clinical and commercial supply, focusing on scale-up, container development, and aseptic fill/finish unit operations.
Role type
Drug Product Development Engineer
Builds
Sterile drug product processes, compositions, and container closure systems for mRNA therapeutics
Domain
Biopharmaceuticals / mRNA therapeutics / Pharmaceutical Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmaceutical sciences knowledge, process development and scale-up, aseptic fill/finish operations, statistical design of experiments (DoE), laboratory characterization techniques, protocol development, data reporting
Preferred skills
Nucleic acid chemistry and biology, nanoparticle formulation technology, GMP compliance, BioPharma industry experience
Technologies
ELN (Electronic Laboratory Notebook), DoE tools, microscopy, particle sizing equipment, opacity testing equipment
Responsibilities
Conduct studies to support scale-up of drug product manufacturing (freeze/thaw, mixing, filling, filtration, lyophilization), develop protocols to evaluate compatibility with processing materials and sterilization processes, plan and execute experiments using DoE, perform routine and non-routine characterization techniques, support manufacturing with process trouble-shooting and investigations, maintain up-to-date ELN with good documentation practices
Seniority
Junior to Mid-level, hands-on IC
